Teva : FDA Oks TRISENOX Injection For Treatment Of Acute Promyelocytic Leukemia

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) said that the U.S. Food and Drug Administration has approved the use of TRISENOX or arsenic trioxide injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva's global safety database for arsenic trioxide.

TRISENOX is contraindicated in patients who are hypersensitive to arsenic.